Container and method of using same



w- D. BRANDON CONTAINER AND METHOD OF USING SAME Filed Nov. 28, 1944 De c. 28, 1948.

Patented Dec. 28, 1948 CONTAINER AND METHOD OF USING SAME Wayne D. Brandon, Skokie, Ill., asslgnor to Baxter Laboratories, Inc.

ration of Delaware Glenview, 111., a corpo- Appllcatlon November 28, 1944, Serial No. 565,536

(cuss-214) l 90mins.

This invention relates to a container and closure means therefor, and more particularly to a container adapted to be employed in the withdrawal and dispensing of blood and blood portions. The invention also relates more specifically to a container closure and to a method of withdrawing and dispensing blood and other fluids. I

An object of the invention is to rovide for aseptically and efliciently handling biologic material, such as, for example, blood, blood plasma, blood serum and similar materials. A further object is to provide a container adapted to be employed as a phlebotomy unit and as a means for dispensing blood or portions thereof without transfer to another container.

A further object is to provide a container adapted for the use of parenteral and other fluids and solutions, permitting the collection and dispensing of the same. Other specific objects and advantages will appear as the specification proceeds.

The invention is illustrated, in preferred embodiments, by the accompanying drawings, in which- Fig. 1 is a vertical sectional view, partly broken away, showing a container and closure embodying my invention; Fig. 2 is a similar view showing a rubber sealing disk upon the'closure and an inlet needle extending therethrough; and Fig. 3 is a similar view showing the unit connected for the dispensing of fluids therefrom.

In the illustration given, A designates a container; and B, a closure plug therefor.

The container A may be of any suitable structure. In the illustration given in Fig. 1, the container is provided with an internal bead Ill upon which the plug B rests. The container A may be of the general shape shown in my Patent No. 2,155,397, dated April 25, 1939, for Container and means for exhausting air therefrom. It will be understood, however, that any suitable type of container may be employed.

The plug B consists of resilient rubber or other suitable resilient sealing material. It is provided with a liquid fiow passage ii and an air inflow passage i2. It will be noted that each of the passages i i and I2 is constricted toward its top portion. Above passage H but separated therefrom by a thin diaphragm I3 is a depression I4 which, in effect, provides a continuation of the upper portion of passage ii. Above the upper portion of passage [2 is a depression or passage l5 separated from passage H .by a thin diaphragm it. It will be understood that the diaphragms i3 and it are readily formed within the passages by molding tools and provide accurately dimensioned films or diaphragms which provide an airtight seal.

The diaphragms I3 and iii are very thin and and are not self-sealing when punctured with a. hypodermic needle. These diaphragms are adapted to be punctured to permit the introduction into 2 the respective passages closed by the diaphragms of an air inlet tube and a fitting for dispensing liquid.

The plug B is also equipped with a passage 25 whichextends through only a portion of the plug. The portion of the plug above this passage 25 indicated at 25 provides a thick resilient diaphragm which may be punctured with a hypodermic needle, but when so punctured is self-sealing upon the withdrawal of the needle.

A sealing disk 22 may be placed over the top surface of the plug B in order to maintain the upper surface of the plug in sterile condition. This disk may be maintained in position by a clamp device 23 which engages one of the external beads on the neck of the container and the top portion of the disk 22. The sealing disk 22 is preferably formed of a resilient material, such as rubber, so that a needle ma be inserted therethrough.

As seen in the drawing, it is important for effective operation of the self-sealing diaphragm 25" that at least one of the passages Ii and i2 be disposed immediately adjacent the passage 25 so that the wall of the passage 25 serves to separate the two passages. The separating wall should be thin and resilient so that when downward pressure is exerted on the thick diaphragm in puncturing the same with a needle, the wall of the passage 25 flexes into the adjacent passage.

In the operation of the device, the container may be partially evacuated and sealed by placing the plug B loosely within the neck of the container while the container is evacuated. If desired, the

plug may be slightly tilted within the neck. Air.

is withdrawn through the passages provided by the loose fitting of the plug within the container. The plug may be seated in sealing position by the sudden change of the pressure to atmospheric pressure or by being pressed into position within the neck of the container. In any event, the passages ll, i2 and 25 aresealed by the diaphragms I3, I 6 and 25 respectively.

When the container is evacuated and the plug placed in sealing position, the container may be capped with or without a disk between the cap and the plug.

When the unit is to be used in a blood transfusion operation, a needle 26 is passed through the resilient sealing disk 22 and the integral selfsealing diaphragm 25 The needle 26 communicates with a valve 21 and tube 28 through which blood flows. The blood is drawn into the container under the influence of vacuum within the container.

When the blood is received within the container, the needle is withdrawn from the diaphragm 25 and the opening formed by the needl in this diaphragm is closed. The diaphragm, by reason of its thickness and resiliency and the arrangement of a passage adjacent the passage 25 into which the wall of the passage 25 may flex, is self-sealing. At the same time, the resilient seal 22 provides a sterile top surface for the plug. The container with its supply of blood hermetically sealed therein may now be banked until it is desired to use the blood.

When the blood is to be dispensed, the resilient sealing disk 22 is removed to provide a sterile top surfac for the plug B. The blunt end of a fitting I9 is then pressed through the thin diaphragm I3 to bring the lower head 20- of the fitting against the lower shoulder of the passage II. If desired, the diaphragm l3 may be slightly punctured with an instrument before introducing the fitting l9. The diaphragm l3 tightly engages the neck of the fitting and tends to draw the fitting upwardly so as to urge the lower head of the fltting tightly against the shoulder of the passage II. The flexible material of the diaphragm I3 thus cooperates with the shoulder I3 to maintain the fitting in effective sealing relation with the plug B. Air and particles within the passage above the shoulder are prevented from entering the container, and liquid within the container is prevented from escaping about the fitting in the withdrawal operation. As is customary, the con-' tainer is inverted in the withdrawal operation and suspended by means of a bail (not shown). The diaphragm. I6 is punctured with the needle I! to permit air to enter the container as the liquid flows therefrom. The fitting may contain a filter drip device 20 of well-known construction, which in turn communicates with a dispensing tube 2|.

To facilitate the passing of the needle through the thick diaphragm 25, the top of the diaphragm may be provided with an integral molded mark, such as an X, thus indicating where the needle is to be pressed into the plug.

When the hypodermic needle is pressed downwardly against the self-sealing diaphragm 25, this resilient diaphragm is flexed downwardly at the portion thereof (normally the center portion) engaged by the needle. In the present construction, the arrangement of the passages, so that the first passage which is closed by the self-sealing diaphragm is separated from the other passages by the resilient wall of the first passage, permits the resilient wall to flex into the free area in the central longitudinal portion of the additional passages when pressure is exerted upon the selfsealing diaphragm. Thus, when the self-sealing diaphragm is to be punctured by the hypodermic needle, the downward pressure of the needle on the upper surface of the diaphragm causes the plug about the walls of the passage at the upper portion thereof to be drawn inwardly and the central longitudinal portion of the walls of this passage to flex outwardly into the free areas provided by the adjacent passages. The thick diaphragm is punctured when in this position. After the needle is withdrawn, the resilient walls of the passage spring back to their original position and tend to urge the punctured portion of the diaphragm upwardly to increase the effectiveness of the seal therein. The apparatus is suitable for the dispensing of any blood portion, such as whole blood, blood plasma, blood serum, etc. It will be understood that after the blood is collected in the container A, it may be centrifuged or allowed to stand to bring about a separation of the formed elements from the liquid portion. In the dispensing operation, the portions may be withdrawn separately or dispensed entirely as a whole blood.

This application is a continuation-in-part of 4 r my co-pending application Serial No. 407,864, filed August 22, 1941, now abandoned.

Although the invention has been described in connection with certain specific embodiments, it will be apparent that modiflcationsand changes may be made without departing from the'spirit and scope of the invention.

I claim:

1. In a container provided with an open neck. closure means for said container comprising a resilient plug engaging the neck of the container in sealing relation therewith, said plug being provided with a passage extending therethrough, a

thick integral resilient diaphragm extending across the upper portion of the passage to close the same, said diaphragm, after being punctured with a hypodermic needle, being self-sealing against the passage of air therethrough when the interior of said container is under vacuum, said plug being provided with an additional passage separated from said first-mentioned passage by the resilient wall thereof, said additional passage providing an area into which said wall is adapted to flex when pressure is exerted on said thick diaphragm in puncturing the same with said needle, and a thin integral resilient diaphragm, substantially non-resistant to lateral flexing, extending across said additional passage to close the same, said thin diaphragm, when punctured by a hypodermic needle, being non-self-sealing against the passage of air when the interior of said container is under vacuum. 7

2. In a container provided with an open neck,

closure means for said container comprising a I interior of said container is under vacuum, said plug being provided with an additional passage separated from said first-mentioned passage by the resilient Wall thereof, said additional passage providing a free area in the central longitudinal portion thereof into which said wall is adapted to flex against the resilience thereof when pressure is exerted on said thick diaphragm in puncturing the same with said needle, the resilience of said wall urging the punctured portion of the thick diaphragm upwardly, after the needle is withdrawn therefrom, to increase the effectiveness of the seal in said thick diaphragm, and a thin integral resilient diaphragm substantially non-resistant to lateral expansion extending across the upper portion of said additional passage to close the same, said thin diaphragm, when punctured by a hypodermic needle, being non-self-sealing against the passage of air when the interior of said container is under vacuum.

3. In a container provided with an open neck, closure means for said container comprising a resilient plug engaging the neck of the container in sealing relation therewith, said plug being provided with a passage extending therethrough, a thick integral resilient diaphragm extending across the upper portion of the passage to close the same, said diaphragm, after being punctured with a hypodermic needle, being self-sealing against the passage of air therethrough when the interior of said container is under vacuum, said plug being provided with a pair of additional passages, each of said additional passages being separated from the first passage by the resilient wall thereof, said additional passages providing areas into which the wall of said first passage is adapted to flex when pressure is exerted on said thick diaphragm in puncturing the same with said needle, and a thin integral resilient diaphragm substantially non-resistant to lateral expansion extending across the upper portion of each of said additional passages to close the same, said thin diaphragms, when punctured by a hypodermic needle, being non-self-sealing against the passage of air when the interior of said container is under vacuum.

4. In a container provided with an open neck,

closure means for said container comprising a resilient plug engaging the neck of the container in sealing relation therewith, said plug being provided with a passage extending therethrough, a thick integral resilient diaphragm extending across the upper portion of the passage to close the same, said diaphragm, after being punctured with a hypodermic needle, being self-sealing against the passage of air therethrough when the interior of said container is under vacuum, said plug being provided with a pair of additional passages separated from said first-mentioned passage by the resilient wall thereof, said additional passages providing free areas in the central longitudinal portions thereof into which said wall is adapted to flex against the resiliency thereof when pressure is exerted on said thick diaphragm in puncturing the same with said needle, the resiliency of said wall urging the punctured portion of the thick diaphragm upwardly after said needle is withdrawn therefrom to increase the effectiveness of the seal in said thick diaphragm, and a thin integral resilient diaphragm substantially non-resistant to lateral flexing extending across each of said additional passages to close the same, said thin diaphragms, when punctured by a hypodermic needle, being non-self-sealing against the passage of air when the interior of said container is under vacuum, said thick diaphragm being of a thickness at least three times as great as the thickness of each of said thin diaphragms.

5. In a container provided with an open neck, closure means for said container comprising a resilient plug engaging the neck of the container in sealing relation therewith, said plug being provided with a passage extending therethrough, a thick integral resilient diaphragm extending across the upper portion of the passage to close the same, said diaphragm, after being punctured with a hypodermic needle of a diameter of approximately one-twelfth the thickness of said diaphragm, being self-sealing against the passage of air therethrough when the interior of the container is under vacuum, said plug being provided with an additional passage separated from said first-mentioned passage by the resilient wall thereof, said additional passage providing a free area in the central longitudinal portion thereof into which said wall is adapted to flex against the resiliency thereof when pressure is exerted on said thick diaphragm in-puncturing the same with'said needle, the resiliency of said wall urging the punctured portionof the thick diaphragm upwardly after said needle is withdrawn therefrom to increase the effectiveness of the seal in said thick diaphragm, and a thin integral resilient diaphragm substantially non-resistant to lateral expansion extending across the upper portion of said additional passage to close the same.

said thin diaphragm when punctured by said needle being non-self-sealing against the passage of air when the interior of said container is under vacuum.

6. In a container provided with an open neck, closure means for said container as set forth in claim 1 wherein said thin diaphragm is puncturable to permit the insertion of an outlet tube in the additional passage and the plug is equipped with a shoulder in said additional passage for engaging an enlarged portion of the outlet tube.

7. In a container provided with an open neck, closure means for said container as set forth in claim 1 wherein said thin diaphragm is puncturable to permit the insertion of an outlet tube in said additional passage and the plug forms in said passage a constricted portion of substantially uniform diameter with a shoulder in an intermediate portion of said passage and at the bottom of said constricted portion for engaging an enlargement on the outlet tube to retain the outlet tube within the passage.

8. In a container provided with an open neck, closure means for said container as set forth in claim 1 wherein said thin diaphragm is puncturable to permit the insertion of an outlet tube in the additional passage and the plug is equipped with a constricted portion in said passage below said diaphragm and a shoulder at the bottom of the constricted portion and above the bottom surface of the plug for engaging an enlarged portion of the outlet tube to retain the outlet tube within the passage, said shoulder being spaced below said diaphragm by a distance at least as great as the radius of the diaphragm.

9. In a container provided with an open neck, closure means for said container comprising a resilient plug engaging the neck of the container in sealing relation therewith, said plug being provided with a pair of passages extending therethrough, each of which is closed in its upper portion by a thin integral diaphragm, said plug having its bottom portion cut away at a point generally between said openings to provide a thick diaphragm, said diaphragm, after being punctured with a point-equipped tube, being selfsealing against the passage of air therethrough when said tube is withdrawn, and a resilient flexible sealing member extending across the top wall of said plug and adapted to form an indentation above either of said passages under the influence of vacuum within said container 1! either of said diaphragms should be broken.

WAYNE D. BRANDON.

REFERENCES CITED The following references are of record in the file of this patent:

UNITED STATES PATENTS Number Name Date 1,413,703 Biehn Apr. 25, 1922 1,737,844 Heineman Dec. 3, 1929 2,004,027 Baxter June 4, 1935 2,085,392 Reichel June 29, 1937 2,108,583 Falk Feb. 13, 1938 2,190,054 Cutter et a1 Feb. 13, 1940 2,222,371 Nesset Nov. 19, 1940 2,231,418 Trotter Feb. 11, 1941 2,236,491 Campbell Mar. 25, 1941 2,276,421 Ross Mar. 17, 1942 2,340,419 Nawaj et a1 -Feb. 1, 1944 

